Chapter 3922: EXTERNAL REVIEW

(1)
To
deny, reduce, or terminate a requested health care service or payment in whole
or in part, including all of the following:

(a)
A
determination that the health care service does not meet the health plan
issuer's requirements for medical necessity, appropriateness, health care
setting, level of care, or effectiveness, including experimental or
investigational treatments;

(b)
A
determination of an individual's eligibility for individual health insurance
coverage, including coverage offered to individuals through a nonemployer
group, to participate in a plan or health insurance coverage;

(c)
A
determination that a health care service is not a covered benefit;

(d)
The
imposition of an exclusion, including exclusions for pre-existing conditions,
source of injury, network, or any other limitation on benefits that would
otherwise be covered.

(2)
Not
to issue individual health insurance coverage to an applicant, including
coverage offered to individuals through a nonemployer group;

(E)
"Covered
person" means a policyholder, subscriber, enrollee, member, or individual
covered by a health benefit plan. "Covered person" does include the covered
person's authorized representative with regard to an internal appeal or
external review in accordance with division (C) of this section. "Covered
person" does not include the covered person's representative in any other
context.

(F)
"Covered
benefits" or "benefits" means those health care services to which a covered
person is entitled under the terms of a health benefit plan.

(G)
"Emergency medical condition" has the same meaning as in section
1753.28 of the Revised
Code.

(H)
"Emergency
services" has the same meaning as in section
1753.28 of the Revised
Code.

(I)
"Evidence-based standard" means the conscientious, explicit, and judicious use
of the current best evidence, based on a systematic review of the relevant
research, in making decisions about the care of individuals.

(L)
"Health
benefit plan" means a policy, contract, certificate, or agreement offered by a
health plan issuer to provide, deliver, arrange for, pay for, or reimburse any
of the costs of health care services, including benefit plans marketed in the
individual or group market by all associations, whether bona fide or non-bona
fide. "Health benefit plan" also means a limited benefit plan, except as
follows. "Health benefit plan" does not mean any of the following types of
coverage: a policy, contract, certificate, or agreement that covers only a
specified accident, accident only, credit, dental, disability income, long-term
care, hospital indemnity, supplemental coverage, as
described in section
3923.37 of the Revised Code,
specified disease, or
vision care; coverage issued as a supplement to liability insurance; insurance
arising out of workers' compensation or similar law; automobile medical payment
insurance; or insurance under which benefits are payable with or without regard
to fault and which is statutorily required to be contained in any liability
insurance policy or equivalent self-insurance; a medicare supplement policy of
insurance, as defined by the superintendent of insurance by rule, coverage
under a plan through medicare, medicaid, or the federal employees benefit
program; any coverage issued under Chapter 55 of Title 10 of the United States
Code and any coverage issued as a supplement to that coverage.

(P)
"Health plan issuer" means an entity subject to the insurance laws and rules of
this state, or subject to the jurisdiction of the superintendent of insurance,
that contracts, or offers to contract to provide, deliver, arrange for, pay
for, or reimburse any of the costs of health care services under a health
benefit plan, including a sickness and accident insurance company, a health
insuring corporation, a fraternal benefit society, a self-funded multiple
employer welfare arrangement, or a nonfederal, government health plan. "Health
plan issuer" includes a third party administrator licensed under Chapter 3959.
of the Revised Code to the extent that the benefits that such an entity is
contracted to administer under a health benefit plan are subject to the
insurance laws and rules of this state or subject to the jurisdiction of the
superintendent.

(Q)
"Health
information" means information or data, whether oral or recorded in any form or
medium, and personal facts or information about events or relationships that
relates to all of the following:

(1)
The past,
present, or future physical, mental, or behavioral health or condition of a
covered person or a member of the covered person's family;

(2)
The
provision of health care services or health-related benefits to a covered
person;

(3)
Payment for
the provision of health care services to or for a covered person.

(S)
"Medical or
scientific evidence" means evidence found in any of the following sources:

(1)
Peer-reviewed scientific studies published in, or accepted for publication by,
medical journals that meet nationally recognized requirements for scientific
manuscripts and that submit most of their published articles for review by
experts who are not part of the editorial staff;

(2)
Peer-reviewed medical literature, including literature relating to therapies
reviewed and approved by a qualified institutional review board, biomedical
compendia and other medical literature that meet the criteria of the national
institutes of health's library of medicine for indexing in index medicus and
elsevier science ltd. for indexing in excerpta medicus;

(3)
Medical journals recognized by the secretary of health and human services under
section 1861(t)(2) of the federal social security act;

(T)
"Person" has the same meaning as in section
3901.19 of the Revised
Code.

(U)
"Protected
health information" means health information related to the identity of an
individual, or information that could reasonably be used to determine the
identity of an individual.

(V)
"Rescind" means to retroactively cancel or discontinue
coverage. "Rescind" does not include
canceling or discontinuing coverage that
only has a prospective effect or
canceling or discontinuing coverage that is
effective retroactively to the extent it is attributable to a failure to timely
pay required premiums or contributions towards the cost of coverage.

(W)
"Retrospective review" means a review conducted after services have been
provided to a covered person.

(A)
A
covered person may make a request for an external review of an adverse benefit
determination.

(B)
All requests
for external review shall be made in writing, including
by electronic means, by the covered person to the
health plan issuer within one hundred eighty days of the date of the
final adverse benefit determination . However, in the case of an expedited external review under
section 3922.09 of the Revised Code,
the review may be requested orally .

(C)
An
adverse benefit determination shall be eligible for internal appeal or external
review, regardless of the cost
of the requested health care service related to the adverse benefit
determination .

(A)
All
health plan issuers shall implement an internal appeal process under which a
covered person may appeal an adverse benefit determination. This process must
be in compliance with the "Patient Protection and
Affordable Care Act of 2010," Pub. L. 111-148,
124 Stat. 119, as amended, and the associated regulations, as well as any other
applicable state laws or rules or federal
regulations.

(B)
Review of a
final adverse benefit determination shall be through an external review under
section 3922.08 ,
3922.09 , or
3922.10 of the Revised
Code.

(C)
All health
plan issuers shall provide notice to covered persons, pursuant to and in
accordance with federal regulations, of all internal appeal processes, external
review processes, the availability of any applicable office of health insurance
assistance, ombudsman program, or other similar program in this state to assist
consumers.

(A)
Except as provided in division (E) of this section, a health plan issuer is not
required to grant a request for a standard external review made under section
3922.08 or
3922.10 of the Revised Code until
the covered person has exhausted the health plan issuer's internal appeal
process.

(B)
An internal
appeal process shall be considered exhausted if a covered person has requested
an internal appeal and has not received a written decision from the health plan
issuer within the time frame required by 29 C.F.R.
2560.503-1 or the health plan issuer fails to adhere to all requirements of the
internal appeals process.

(C)
Notwithstanding division (B) of this section, the internal appeals process will
not be deemed exhausted based on de minimis violations that do not cause, and
are not likely to cause, prejudice or harm to the covered person so long as the
health plan issuer demonstrates that the violation was for good cause or due to
matters beyond the control of the health plan issuer and that the violation
occurred in the context of an ongoing, good faith exchange of information
between the health plan issuer and the covered person, and is not reflective of
a pattern or practice of noncompliance, except that:

(1)
If
the health plan issuer denies a request for external review under this
division, the covered person may request written explanation from the health
plan issuer, and the health plan issuer shall provide the explanation within
ten days, including a specific description of its basis, if
any, for asserting that the delay should not cause the internal appeals process
to be considered exhausted;

(2)
The
covered person may request review by the superintendent of the health plan
issuer's explanation provided under division (C)(1) of this section and if the
superintendent affirms the health plan issuer's explanation, the covered person
may, within ten days of the superintendent's notice of decision, resubmit and
pursue the internal appeal process. Time periods for refiling the internal
appeal shall begin to run upon receipt of such notice by the covered
person.

(D)
Notwithstanding division (B) of this section, a covered person shall not make a
request for an external review of an adverse benefit determination involving a
retrospective review determination made pursuant to a utilization review until
the covered person has exhausted the health plan issuer's internal appeals
process.

(E)
A request
for an external review of an adverse benefit determination may be made before
the covered person has exhausted the health plan issuer's internal appeals
procedures whenever the health plan issuer agrees to waive the exhaustion
requirement. If the internal appeal process is waived, the covered person may
file a request in writing for a standard external review under section
3922.08 or
3922.10 of the Revised
Code.

(F)
Notwithstanding any other section in this chapter, health plan issuers offering
individual health insurance coverage, including coverage offered to individuals
through nonemployer groups shall not require more than one level of internal
appeal before the individual may request an external review.

(A)
A health
plan issuer shall afford the opportunity for an external review by an
independent review organization for an adverse benefit determination if the
determination involved a medical judgment or if the decision was based on any
medical information, pursuant to the following sections:

(B)
A
health plan issuer shall afford the opportunity for an external review by the
superintendent of insurance for an adverse benefit determination by the health
plan issuer based on a contractual issue that did not involve a medical
judgment or any medical information, pursuant to section
3922.11 of the Revised
Code.

(C)
For an
adverse benefit determination in which emergency medical services have been
determined to be not medically necessary or appropriate after an external
review pursuant to division (A) of this section, the health plan issuer shall
afford the covered person the opportunity for an external review by the
superintendent of insurance, based on the prudent layperson standard, pursuant
to section
3922.11 of the Revised
Code.

(D)
Upon receipt
of a request for an external review from a covered person, the health plan
issuer shall review it for completeness as prescribed under any associated
rules, policies, or procedures adopted by the superintendent.

(1)
If
the request is complete, the health plan issuer shall initiate an external
review in accordance with any associated rules, policies, or procedures adopted
by the superintendent of insurance and shall notify the covered person in
writing, in a form specified by the superintendent of insurance, that the
request is complete. This notification shall include both of the following:

(a)
The
name and contact information for the assigned independent review organization
or the superintendent of insurance, as applicable, for the purpose of
submitting additional information;

(b)
Except for when an expedited request is made under section
3922.09 or
3922.10 of the Revised Code, a
statement that the covered person may, within ten
business days after the date of receipt of the notice, submit, in writing,
additional information for either the independent review organization or the
superintendent of insurance to consider when conducting the external
review.

(2)
If the
request for an external review is not complete, the health plan issuer shall,
in accordance with any associated rules, policies, or procedures adopted by the
superintendent of insurance, inform the covered person in writing, including
what information is needed to make the request complete.

(1)
If the health plan issuer denies a
request for an external review on the basis that the adverse benefit
determination is not eligible for an external review, the health plan issuer
shall notify the covered person in writing of both of the following:

(2)
If
the health plan issuer denies a request for external review on the basis that
the adverse benefit determination is not eligible for an external review, the
covered person may appeal the denial to the superintendent of
insurance.

(3)
Regardless
of a determination made by a health plan issuer, the superintendent of
insurance may determine that a request is eligible for external review. The
superintendent's determination shall be made in accordance with the terms of
the covered person's benefit plan and shall be subject to all applicable
provisions of this chapter.

(1)
If an external review of an adverse
benefit determination is granted, the superintendent, according to any rules,
policies, or procedures adopted by the superintendent shall assign an
independent review organization from the list of organizations maintained by
the superintendent under section
3922.13 of the Revised Code to
conduct the external review and shall notify the health plan issuer of the name
of the assigned independent review organization.

(2)
The
assignment of an approved independent review organization shall be done on a
random basis from those independent review organizations qualified to conduct
the review in question based on the nature of the health care service that is
the subject of the adverse benefit determination.

(3)
The
superintendent of insurance shall not choose an independent review organization
with a conflict of interest, as prescribed under section
3922.14 of the Revised
Code.

(G)
In its
review of an adverse benefit determination under section
3922.08 ,
3922.09 , or
3922.10 of the Revised Code, an
assigned independent review organization is not bound by any decisions or
conclusions reached by the health plan issuer during its utilization review
process or internal appeals process. The organization is not required to, but
may, accept and consider additional information submitted after the end of the
ten-business-day period described in division (D)(1)(b) of this
section.

(1)
An independent review organization
assigned to review an adverse benefit determination shall provide written
notice of its decision to either uphold or reverse the determination within
thirty days of receipt by the health plan issuer
of a request for a standard review or a standard review involving an
experimental or investigational treatment, or within seventy-two hours of
receipt by the health plan issuer of an expedited
request.

(f)
References to the evidence or documentation, including any evidence-based
standards used, that were considered in reaching its decision.

(I)
Upon receipt
of a notice by an independent review organization to reverse the adverse
benefit determination, a health plan issuer shall immediately provide coverage
for the health care service or services in question.

Except for when an
expedited request is made under section
3922.09 or
3922.10 of the Revised Code, an
independent review organization shall forward upon receipt a copy of any
information received from a covered person pursuant to division (D)(1) of
section 3922.05 of the Revised Code, as
well as any other information received from the covered person, to the health
plan issuer.

Upon receipt of that
information or the information described in division (K) of section
3922.10 of the Revised Code, a
health plan issuer may reconsider its adverse benefit determination and provide
coverage for the health service in question.

Reconsideration of an
adverse benefit determination by a health plan issuer based upon receipt of information under this section
shall not delay or terminate an external review.

If a health plan issuer
reverses an adverse benefit determination under this section, the health plan
issuer shall notify, in writing and within one business day of making such a
decision, the covered person, the assigned independent review organization, and
the superintendent of insurance.

Upon receipt of such a
notification, the assigned independent review organization shall terminate the
associated external review.

In addition to the information provided under division (D)(1)(b) of section
3922.05 , division (B) of section
3922.08 , division (C) of section
3922.09 , and division (D) of
section 3922.10 of the Revised Code, an
assigned independent review organization, to the extent that such documents are
available and appropriate, shall consider all of the following when conducting
its review:

(D)
The terms of
coverage under the covered person's health benefit plan to ensure that the
independent review organization's decision is not contrary to the terms of the
plan;

(E)
The most
appropriate practice guidelines, including evidence-based standards, and
practice guidelines developed by the federal government, and national or
professional medical societies, boards, and associations;

(F)
Any
applicable clinical review criteria developed and used by the health plan
issuer or its designated utilization review organization;

(G)
The opinion
of the independent review organization's clinical reviewer or reviewers after
considering the other sources described in this section.

(A)
The
provisions of this section apply only to standard reviews, which are not
expedited and do not involve an experimental or investigational
treatment.

(B)
Within five
days after the receipt of a request for an external review that is complete and
valid, the health plan issuer shall provide to the assigned independent review
organization all documents and information considered in making the adverse
benefit determination.

(C)
An external
review shall not be delayed due to failure on the part of the health plan
issuer to provide the information required under division (B) of this
section.

(1)
An
independent review organization may reverse an adverse benefit determination if
the information required under division (B) of this section is not provided in
the allotted time. The independent review organization may also grant a request
from the health plan issuer for more time to provide the required
information.

(2)
If an
adverse benefit determination is reversed under division (D)(1) of this
section, the independent review organization shall notify, within one business
day of making the decision, the covered person, the health plan issuer, and the
superintendent of insurance.

(A)
A
covered person may make a request for an expedited external review, except as
provided in division (I) of this section:

(1)
After an adverse benefit determination, if both of the following apply:

(a)
The
covered person's treating physician certifies that the adverse benefit
determination involves a medical condition that could seriously jeopardize the
life or health of the covered person, or would
jeopardize the covered person's ability to regain maximum function, if
treated after the time frame of an expedited internal
appeal;

(b)
The
covered person has filed a request for an expedited internal
appeal.

(2)
After a final adverse benefit determination, if either of the following apply:

(a)
The
covered person's treating physician certifies that the adverse benefit
determination involves a medical condition that could seriously jeopardize the
life or health of the covered person, or would jeopardize the covered person's
ability to regain maximum function, if treated after the time frame of a
standard external review;

(b)
The
final adverse benefit determination concerns an admission, availability of
care, continued stay, or health care service for which the covered person
received emergency services, but has not yet been discharged from a
facility.

(B)
Immediately upon receipt of a request for an expedited external review, the
health plan issuer shall determine if the request is complete under any
associated rules, policies, or procedures adopted by the superintendent of
insurance and eligible for expedited external review under division
(A) of
this section. The health plan issuer shall immediately notify the covered
person of its determination in accordance with any associated rules, policies,
or procedures adopted by the superintendent of insurance.

(C)
If
a request for an expedited review is complete and eligible, the health plan
issuer shall immediately provide or transmit all necessary documents and
information considered in making the adverse benefit determination in question
to the assigned independent review organization electronically, or by
facsimile or other available expeditious
method.

(D)
In addition
to the information transmitted under division (C) of this
section, the assigned independent review organization shall also consider
relevant information as required under section
3922.07 of the Revised
Code.

(E)
As
expeditiously as the covered person's medical condition requires, but no more
than seventy-two hours after receipt by the health plan issuer of
a request for an expedited, external review, the assigned independent
review organization shall uphold or reverse the adverse benefit
determination.

(F)
If a health
plan issuer fails to provide the documents and information as required in
division (C) of this section, the independent review
organization shall not delay the external review and may accordingly reverse
the adverse benefit determination.

(G)
An
independent review organization shall promptly notify the covered person,
health plan issuer, and superintendent of insurance of any decision made under
this section. If such a notice is not made in writing, the independent review
organization, shall provide, within forty-eight hours of making the decision,
written confirmation, including the information required under division (H)(3)
of section
3922.05 of the Revised Code, of
its decision to the covered person, the health plan issuer, and the
superintendent of insurance.

(H)
Upon receipt of a notice by an independent review organization to reverse the
adverse benefit determination, a health plan issuer shall immediately provide
coverage for the health care service or services in question.

(I)
An
expedited, external review may not be provided for retrospective final adverse
benefit determinations.

The provisions of this
section apply only to external reviews that involve an experimental or
investigational treatment.

(A)
A
covered person may request an external review of an adverse benefit
determination based on the conclusion that a requested health care service is
experimental or investigational, except when the requested health care service
is explicitly listed as an excluded benefit under the covered person's benefit
plan.

(B)
To be
eligible for an external review under this section, a covered person's treating
physician shall certify that one of the following situations is applicable:

(1)
Standard health care services have not been effective in improving the
condition of the covered person .

(1)
A covered person may request orally or by
electronic means an expedited review under this section if the person's
treating physician certifies that the requested health care service in question
would be significantly less effective if not promptly initiated.

(2)
Immediately upon receipt of a request for an expedited external review, the
health plan issuer shall determine if the request is complete under any
associated rules, policies, or procedures adopted by the superintendent of
insurance and eligible for expedited external review under division
(C)(1)
of this section. The health plan issuer shall immediately notify the covered
person of its determination in accordance with any associated rules adopted by
the superintendent of insurance.

(D)
The
health plan issuer shall provide to the assigned independent review
organization all documents and information considered in making the adverse
benefit determination within whichever of the following applies:

(1)
Within five days after the receipt of a request for a standard
external review;

(2)
For an
expedited external review, immediately electronically,
or by facsimile or any other available expeditious
method.

(E)
An
independent review organization assigned by the superintendent of insurance
under division (F) of section
3922.05 of the Revised Code shall
do both of the following:

(1)
Select at
least one clinical reviewer, pursuant to divisions (F) and (G) of this section
to conduct the external review;

(2)
Make a decision to uphold or reverse the adverse benefit determination based
upon the opinion of the clinical reviewer or reviewers.

(F)
In
selecting clinical reviewers under division (E) of this section, the assigned
independent review organization shall select physicians or other health care
professionals who meet the minimum qualifications described in section
3922.15 of the Revised Code.

(G)
Neither the covered person, nor the health plan issuer, shall choose or have
any influence over the choice of the clinical reviewer or reviewers chosen
under division (E) of this section.

(b)
A
description of the indicators relevant to determining whether there is
sufficient evidence to demonstrate that the recommended or requested therapy is
more likely than not to be more beneficial to the covered person than any
available standard health care service, and that the adverse risks of the
requested health care service would not be substantially greater than those of
available standard health care services;

(c)
A
description and analysis of any medical or scientific evidence considered in
reaching the opinion;

(d)
A
description and analysis of any evidence-based standard considered;

(e)
Information on whether the reviewer's rationale for the opinion is based on
division (K)(2)(b) or (c) of this
section.

(I)
An
external review shall not be delayed due to failure on the part of the health
plan issuer to provide the information required under division (D) of this
section.

(1)
An independent review organization may
reverse an adverse benefit determination, if the information required under
division (D) of this section is not provided in the allotted time. The
independent review organization may also grant a request from the health
plan issuer for more time to provide the required information.

(2)
If
an adverse benefit determination is reversed under division (J)(1) of this
section, the independent review organization shall immediately notify the
covered person, the health plan issuer, and the superintendent of
insurance.

(1)
Each clinical reviewer shall review all
of the information received pursuant to division (D) of this section, as well
as any other information submitted in writing by the covered person pursuant to
division (D) of section
3922.05 of the Revised
Code.

(2)
In addition
to the documents and information provided pursuant to division (D) of this
section and division (D) of section
3922.05 of the Revised Code, each
clinical reviewer shall consider the following:

(b)
Whether the
requested health care service has been approved by the federal food and drug
administration, if applicable, for the condition;

(c)
Whether medical or scientific evidence, or evidence-based standards,
demonstrate that the expected benefits of the requested health care service is
more likely than not to be beneficial to the covered person than any available
standard health care service, and that the adverse risks of the requested
health care service would not be substantially greater than those of available
standard health care services.

(L)
Within one business day after the receipt of any such information submitted by
the covered person in accordance with division (K)(1) of this section, the
independent review organization shall forward the information to the health
plan issuer. Upon receipt of any such forwarded information in accordance with
division (K)(1) of this section, a health plan issuer may reconsider its
adverse benefit determination as described in section
3922.06 of the Revised
Code.

(1)
Within thirty days after the date of
receipt by the health plan issuer of a request
for a standard external review, or within seventy-two hours of receipt
by the health plan issuer of a request for an
expedited external review, the assigned independent review organization shall
provide written notice of its decision to uphold or reverse the adverse benefit
determination to the covered person, the health plan issuer, and the
superintendent of insurance.

(a)
If a majority of the clinical reviewers
recommend that the requested health care service should be covered, the
independent review organization shall make a decision to reverse the health
plan issuer's adverse benefit determination.

(b)
If
a majority of the clinical reviewers recommend that the recommended or
requested health care service or treatment should not be covered, the
independent review organization shall make a decision to uphold the health plan
issuer's adverse benefit determination.

(i)
If the clinical reviewers are evenly
split as to whether the adverse benefit determination should be reversed or
upheld, the independent review organization shall obtain the opinion of an
additional clinical reviewer in order for the independent review organization
to make a decision based on the opinions of a majority of the clinical
reviewers pursuant to this division.

(ii)
The additional clinical reviewer selected shall use the same information to
reach an opinion as the clinical reviewers who have already submitted their
opinions pursuant to this section.

(iii)
The selection of the additional clinical reviewer under this division shall not
extend the time within which the assigned independent review organization is
required to make a decision.

(3)
The
independent review organization shall include in the notice provided pursuant
to division (M)(1) of this section all of the following:

(a)
A
general description of the reason for the request for external
review;

(b)
The written
opinion of each clinical reviewer, including the recommendation of each
clinical reviewer as to whether the recommended or requested health care
service or treatment should be covered and the rationale for that
recommendation;

(c)
The date the
independent review organization was assigned by the superintendent to conduct
the external review;

(N)
Upon receipt of a notice of a decision by an independent review organization
pursuant to division (M)(1) of this section reversing the adverse benefit
determination, a health plan issuer shall immediately provide coverage of the
requested health care service in question.

(A)
The
superintendent of insurance shall establish and maintain a system for receiving
and reviewing requests for external review for adverse benefit determinations
where the determination by the health plan issuer was based on a contractual
issue and did not involve a medical judgment or a determination based on any
medical information, except for emergency services, as specified in division
(C) of section
3922.05 of the Revised
Code.

(B)
A health
plan issuer shall submit a request for external review pursuant to division (B)
or (C) of section
3922.05 of the Revised Code to the
superintendent, in accordance with any associated rules, policies, or
procedures adopted by the superintendent of insurance.

(C)
On
receipt of a request from a health plan issuer, the superintendent shall
consider whether the health care service is a service covered under the terms
of the covered person's policy, contract, certificate, or agreement, except
that the superintendent shall not conduct a review under this section unless
the covered person has exhausted the health plan issuer's internal
appeal process, pursuant to sections
3922.03 and
3922.04 of the Revised Code. The
health plan issuer and covered person shall provide the superintendent with any
information required by the superintendent that is in their possession and is
germane to the review.

(D)
Unless the
superintendent is not able to do so because making the determination requires a
medical judgement or a determination based on medical information, the
superintendent shall determine whether the health care service at issue is a
service covered under the terms of the covered person's contract, policy,
certificate, or agreement. The superintendent shall notify the covered
person and the health plan issuer of the
superintendent's determination.

(E)
If
the superintendent notifies the health plan issuer that making the
determination requires a medical judgement or a determination based on medical
information, the health plan issuer shall initiate an external review under
this chapter.

(F)
If the
superintendent determines that the health service is a covered service, the
health plan issuer shall cover the service.

(G)
If
the superintendent determines that the health care service is not a covered
service, the health plan issuer is not required to cover the service or afford
the covered person an external review
by an independent review organization.

(A)
An external
review decision is binding on the health plan issuer except to the extent the
health plan issuer has other remedies available under applicable state law, or
unless the superintendent of insurance determines that, due to the facts and
circumstances of an external review, a second external review is
required.

(B)
An external
review decision is binding on the covered person except to the extent the
covered person has other remedies available under applicable federal or state
law, or unless the superintendent determines that, due to the facts and
circumstances of an external review, a second external review is
required.

(C)
A covered
person may not file a subsequent request for external review involving the same
adverse benefit determination for which the covered person has already received
an external review decision pursuant to this chapter, except in the event that
new medical or scientific evidence is submitted to the health plan
issuer.

The superintendent shall accredit independent review organizations as
prescribed by this section.

(A)
The
superintendent shall develop an application form to accredit and renew
accreditation of an independent review organization.

(B)
An
independent review organization seeking to be accredited by the superintendent,
or to renew its accreditation, shall submit the application form and include
with the form all documentation and information necessary for the
superintendent to determine if the independent review organization satisfies
the minimum qualifications established under section
3922.14 of the Revised
Code.

(1)
Except as
provided in division (C)(2) of this section, an independent review organization
is eligible for accreditation by the superintendent under this section only if
it is accredited by a nationally recognized private accrediting entity that the
superintendent has determined has accreditation standards that are equivalent
to or exceed the minimum qualifications for independent review organizations
under section
3922.14 of the Revised
Code.

(2)
The
superintendent may approve independent review organizations that are not
accredited by a nationally recognized private accrediting entity, if there are
no acceptable nationally recognized private accrediting entities providing
independent review organization accreditation.

(D)
An
independent review organization shall apply to renew its accreditation on an
annual basis.

(E)
If the
superintendent determines that an independent review organization has lost its
accreditation by a nationally recognized private accrediting entity or no
longer satisfies the minimum requirements established under section
3922.14 of the Revised Code, the
superintendent shall revoke the independent review organization's accreditation
and shall remove the independent review organization from the list of
independent review organizations approved to conduct external
reviews.

(A)
To
be accredited by the superintendent of insurance to conduct external reviews
under section
3922.13 of the Revised Code, in
addition to the requirements provided in section
3922.13 of the Revised Code and
any associated rules adopted by the superintendent, an independent review
organization shall do all of the following:

(1)
Develop and maintain written policies and procedures that govern all aspects of
both the standard external review process and the expedited external review
process set forth in this chapter, including a quality assurance mechanism that
does all of the following:

(a)
Ensures that
external reviews are conducted within the time frames prescribed under this
chapter and that the required notices are provided in a timely
manner;

(b)
Ensures the
selection of qualified and impartial clinical reviewers to conduct external
reviews on behalf of the independent review organization;

(c)
Ensures that chosen clinical reviewers are suitably matched according to their
area of expertise to specific cases and that the independent review
organization employs or contracts with an adequate number of clinical reviewers
to meet this requirement;

(d)
Ensures the confidentiality of medical and treatment records and clinical
review criteria;

(e)
Ensures that
any person employed by, or who is under contract with, the independent review
organization adheres to the requirements of this chapter.

(2)
Maintain a toll-free telephone service to receive information on a
twenty-four-hour-a-day, seven-days-a-week basis related to external reviews
that is capable of accepting, recording, and providing appropriate instruction
to incoming telephone callers during other than normal business
hours;

(3)
Agree to
maintain and provide to the superintendent, upon request and in accordance with
any associated rules, policies, or procedures adopted by the superintendent of
insurance, the information prescribed in section
3922.17 of the Revised
Code.

(B)
An
independent review organization may not own or control, be a subsidiary of or
in any way be owned or controlled by, or exercise control with a
health plan issuer, a
national, state or local trade association of health plan
issuers, or a national, state, or local trade association of health care
providers.

(1)
Neither the independent review
organization selected to conduct the external review nor any clinical reviewer
assigned by the independent organization to conduct the external review may
have a material, professional, familial, or financial affiliation with any of
the following:

(a)
The health
plan issuer that is the subject of the external review, or any officer,
director, or management employee of the health plan issuer;

(b)
The
covered person whose treatment is the subject of the external review;

(c)
The
health care provider, or the health care provider's medical group or
independent practice association, recommending the health care service or
treatment that is the subject of the external review;

(d)
The
facility at which the recommended health care service would be
provided;

(e)
The
developer or manufacturer of the principal drug, device, procedure, or other
therapy being recommended for the covered person whose treatment is the subject
of the external review.

(2)
The
superintendent may make a determination as to whether an independent review
organization or a clinical reviewer of the independent review organization has
a material professional, familial, or financial conflict of interest for
purposes of division (C)(1) of this section. In making this determination, the
superintendent may take into consideration situations where an independent
review organization, or a clinical reviewer, may have an apparent conflict of
interest, but that the characteristics of the relationship or connection in
question are such that they do not fall under the definition of conflict of
interest provided under division (D)(1) of this section. If the superintendent
determines that a conflict of interest exists, the superintendent shall
disallow an independent review organization or a clinical reviewer from
conducting the external review in question. Such determinations related to
conflicts of interest are the sole discretion of the superintendent of
insurance.

(1)
An independent review organization that
is accredited by a nationally recognized private accrediting entity that has
independent review accreditation standards that the superintendent has
determined are equivalent to or exceed the minimum qualifications of this
section shall be presumed in compliance with this section to be eligible for
accreditation by the superintendent under section 3922.14 of the Revised
Code.

(2)
The
superintendent shall initially review and periodically review the independent
review organization accreditation standards of a nationally recognized private
accrediting entity to determine whether the entity's standards are, and
continue to be, equivalent to or exceed the minimum qualifications established
under this section. The superintendent may accept a review conducted by the
national association of insurance commissioners for the purpose of the
determination under this division.

(3)
Upon request, a nationally recognized, private accrediting entity shall make
its current independent review organization accreditation standards available
to the superintendent or the national association of insurance commissioners in
order for the superintendent to determine if the entity's standards are
equivalent to or exceed the minimum qualifications established under this
section. The superintendent may exclude any private accrediting entity that is
not reviewed by the national association of insurance commissioners.

(E)
An
independent review organization shall be unbiased in its review of adverse
benefit determinations and shall establish and maintain written procedures to
ensure that it is unbiased.

All clinical reviewers
assigned by an independent review organization to conduct external reviews
shall have the same license as the health care provider of the service in
question, and shall be physicians or other appropriate health care providers
who meet all of the following minimum qualifications:

(A)
Be
an expert in the treatment of the medical condition that is the subject of the
external review;

(B)
Be
knowledgeable about the requested health care service through clinical
experience, within the last three years, treating patients with the same, or a
similar, medical condition, and, in the case of an
external review of an experimental or investigational health care service, be
an expert, through clinical experience in the last three years, in the
treatment of the covered person's condition and have knowledge of the requested
health care service;

(C)
Hold a nonrestricted license in a state of the United States and, for
physicians, a current certification by a recognized American medical specialty
board in the area or areas appropriate to the subject of the external
review;

(D)
Have no
history of disciplinary actions or sanctions, including loss of staff
privileges or participation restrictions, that have been taken or are pending
by any hospital, governmental agency or unit, or regulatory body that raise a
question as to the clinical reviewer's physical, mental, or professional
competence or moral character.

(A)
Nothing in this chapter shall be construed to create a cause of action against
any of the following:

(1)
An employer
that provides health care benefits to employees through a health plan
issuer;

(2)
A clinical
reviewer or independent
review organization that participates in an external review under this
chapter;

(3)
A health
plan issuer that provides coverage for benefits pursuant to this
chapter.

(B)
An
independent review organization and any clinical reviewer an independent review organization uses
in conducting an external review under this chapter is not liable in damages in
a civil action for injury, death, or loss to person or property and is not
subject to professional disciplinary action for making, in good faith, any
finding, conclusion, or determination required to complete the external
review.

(C)
This section
does not grant immunity from civil liability or professional disciplinary
action to an independent review organization or clinical reviewer for
an action that is outside the scope of authority granted under this
chapter.

(1)
An
independent review organization assigned pursuant to sections
3922.08 ,
3922.09 , or
3922.10 of the Revised Code to
conduct an external review shall maintain written records in accordance with
the associated rules established by the superintendent, in the aggregate by
state, and by the health plan issuer, on all external reviews requested and
conducted during a calendar year.

Each independent review organization shall submit this
information to the superintendent, upon request, in a report in the format
specified by the superintendent that shall include, in the aggregate by state
and for each health plan issuer, all of the following:

(d)
A summary of
the types of requested health care services or cases for which an external
review was sought;

(e)
The number
of external reviews that were terminated as the result of a reconsideration by
the health plan issuer of an adverse benefit determination after the receipt of
additional information from the covered person under section
3922.05 of the Revised
Code;

(f)
The costs
associated with external reviews, including the amounts charged by the
independent review organization to conduct the reviews;

(g)
The medical
specialty, or the type, of clinical reviewer used to conduct each external
review, as related to the specific medical condition of the covered
person;

(2)
The
independent review organization shall retain the written records required under
division (A)(1) of this section for at least three years.

(B)
A health
plan issuer shall maintain written records on all requests made for an external
review under this chapter and shall provide all such information as required by
any associated rules, policies, or procedures adopted by the superintendent of
insurance. A health plan issuer shall maintain written records on all requests
for external review for at least three years.

(C)
The
superintendent shall compile and annually publish the information collected
under this section and report the information to the governor, the speaker and
minority leader of the house of representatives, the president and minority
leader of the senate, and the chairs and ranking minority members of the house
and senate committees with jurisdiction over health and insurance
issues.

The health plan issuer against which a request for a standard external review
or an expedited external review is filed shall pay the cost of the external
review, including the cost of any external review that is required at the
direction of the superintendent.

If
the superintendent determines that, due to the facts and circumstances of an
external review, a second external review is required, the health plan issuer
shall pay the costs of the second review.

(A)
Each health plan issuer shall include a description of its external review
procedures, including the superintendent's contractual review, in, or attached
to, the policy, certificate, membership booklet, or outline of coverage, or
other evidence of coverage it provides to covered persons. This disclosure
shall be in a form prescribed by the superintendent in any associated rules,
policies, or procedures.

(B)
The
disclosure required by division (A) of this section shall include a statement
that informs the covered person of the covered person's right to file a request
for an external review of an adverse benefit determination with the health plan
issuer. The statement shall do all of the following:

(1)
Explain that external review is available when the adverse benefit
determination involves an issue of medical necessity, appropriateness, health
care setting, and level of care or effectiveness;

(3)
Inform the covered person that, when filing a request for an external review,
the covered person will be required to authorize the release of the covered
person's medical records as necessary to conduct the external review.

(1)
When a health plan issuer notifies a
covered person of an adverse benefit determination, the health plan issuer
shall also notify the covered person, in writing, of the covered person's right
to request an external review, pursuant to section
3922.08 ,
3922.09 ,
3922.10 , or
3922.11 of the Revised
Code.

(2)
As part of
the written notice required under division (C)(1) of this section, a health
plan issuer shall include all of the following:

(a)
Information sufficient to identify the claim or health care service involved,
including the health care provider, and the date of service and claim amount,
if applicable;

(b)
A
description of the reason or reasons for the adverse benefit determination,
including the denial code, such as the claim adjustment reason code and the
remittance advice remark code, and each code's corresponding meaning;

(c)
A
description of the health plan issuer's standard, if any, that was used in
making the determination;

(d)
A
description of the available internal appeals and external review processes,
including information regarding how to initiate an appeal and an external
review;

(e)
Disclosure
of the availability of assistance from the superintendent with the internal
appeals and external review processes, including the web site, telephone
number, and mailing address of the superintendent's office of consumer
services.

(3)
In the case
of a notice of a final adverse benefit determination subsequent to an internal
appeal, in addition to the information required under division (C)(2) of this
section, the notice must also include a discussion of the decision.

(4)
Any
written notice provided under division (C) of this section shall be in a form
prescribed by the superintendent of insurance.

(D)
For
an adverse benefit determination that is not a final adverse benefit
determination, the health plan issuer shall include with the notice required
under division (C) of this section a statement informing the covered person of
all of the following:

(1)
If the
covered person's treating physician certifies in writing that the covered
person has a medical condition where the time frame for completion of an
expedited review of an internal appeal involving an adverse benefit
determination would seriously jeopardize the life or health of the covered
person or jeopardize the covered person's ability to regain maximum function,
the covered person may file a request for an expedited external review to be
conducted simultaneously with the expedited internal appeal, pursuant to
section 3922.09 of the Revised
Code.

(2)
If the
adverse benefit determination involves a denial of coverage based on a
determination that the recommended or requested health care service or
treatment is experimental or investigational and the covered person's treating
physician certifies in writing that the recommended or requested health care
service or treatment that is the subject of the adverse benefit determination
would be significantly less effective if not promptly initiated, the covered
person may file a request for an expedited external review to be conducted
simultaneously with the expedited internal appeal, pursuant to section
3922.09 or
3922.10 of the Revised
Code.

(3)
If the
covered person has requested an internal appeal and the health plan issuer has
not issued a written decision to the covered person within thirty days
following the date the covered person files the request, and the covered person
has not requested or agreed to a delay, the covered person may file a request
for external review pursuant to section
3922.08 of the Revised Code and
may be considered to have exhausted the health plan issuer's internal appeals
process for purposes of section
3922.04 of the Revised
Code.

(E)
For a final
adverse benefit determination, the health plan issuer shall include with the
notice required under division (C) of this section a statement informing the
covered person of all of the following:

(1)
A
written request for an external review must be submitted to the health plan
issuer within one hundred eighty days after the date of the notice of final
adverse benefit determination .

(2)
If
the covered person's treating physician certifies in writing that the covered
person has a medical condition for which the time frame for completion of a
standard external review pursuant to section
3922.08 of the Revised Code would
seriously jeopardize the life or health of the covered person or would
jeopardize the covered person's ability to regain maximum function, the covered
person may file a request for an expedited external review pursuant to section
3922.09 of the Revised
Code.

(a)
If the final adverse benefit
determination concerns a health care service for which the covered person
received emergency services, but has not been discharged from a facility, the
covered person may request an expedited external review pursuant to section
3922.09 of the Revised
Code.

(b)
If the final
adverse benefit determination concerns denial of coverage based on a
determination that the recommended or requested health care service or
treatment is experimental or investigational, the covered person may file a
request for an external review to be conducted pursuant to section
3922.10 of the Revised Code, or if
the covered person's treating physician certifies in writing that the
recommended or requested health care service that is the subject of the request
would be significantly less effective if not promptly initiated, the covered
person may request an expedited external review to be conducted under section
3922.10 of the Revised
Code.

(1)
In addition to any
information required to be provided under divisions (D) and (E) of this
section, the health plan issuer shall include a description of both the
standard and expedited external review procedures the health plan issuer is
required to produce pursuant to this chapter, highlighting in the external
review procedures the sections of the Revised Code that give the covered person
the opportunity to submit additional information.

(2)
The
health plan issuer shall also include any forms used to process an external
review, including an authorization form, or other document approved by the
superintendent that complies with the requirements of
45 C.F.R.
164.508 , by which the covered person, for
purposes of conducting an external review under this chapter, authorizes the
health plan issuer and the covered person's treating health care provider to
disclose protected health information, including medical records, concerning
the covered person that are related in any manner to the external
review.

Consistent with the Rules of Evidence, a written decision or opinion prepared
by an independent review organization under this chapter shall be admissible in
any civil action related to the coverage decision that was the subject of the
decision or opinion. The independent review organization's decision or opinion
shall be presumed to be a scientifically valid and accurate description of the
state of medical knowledge at the time it was written.

Consistent with the Rules of Evidence, any party to a civil
action related to a plan's decision involving an investigational or
experimental drug, device, or treatment may introduce into evidence any
applicable medicare reimbursement standards established under Title XVIII of
the "Social Security Act," 49 Stat. 620 (1935),
42 U.S.C.A.
301 , as amended.

(A)
When a
record containing information pertaining to the medical history, diagnosis,
prognosis, or medical condition of a covered person is provided to the
superintendent of insurance for any reason under this chapter or sections
1751.77 to
1751.87 of the Revised Code,
regardless of the source, the superintendent shall maintain the confidentiality
of the record. The record in the superintendent's possession is not a public
record under section
149.43 of the Revised Code, except
to the extent that information from the record is used in preparing reports
under section
3922.17 of the Revised
Code.

(B)
Notwithstanding division (A) of this section, the superintendent may share a
record that is the subject of this section in connection with the investigation
or prosecution of any illegal or criminal activity with the chief deputy
rehabilitator, the chief deputy liquidator, other deputy rehabilitators and
liquidators, and any other person employed by, or acting on behalf of, the
superintendent pursuant to Chapter 3901. or 3903. of the Revised Code, with
other local, state, federal, and international regulatory and law enforcement
agencies, with local, state, and federal prosecutors, and with the national
association of insurance commissioners and its affiliates and subsidiaries,
provided that the recipient agrees to maintain the confidential or privileged
status of the confidential or privileged record and has authority to do
so.

(C)
Nothing in
this section shall prohibit the superintendent from receiving records in
accordance with section
3901.045 of the Revised
Code.

(D)
The
superintendent may enter into agreements governing the sharing and use of
records consistent with the requirements of this section.

(E)
No waiver of
any applicable privilege or claim of confidentiality in the records that are
the subject of this section shall occur as a result of sharing or receiving
records as authorized in divisions (B) and (C) of this section.

The superintendent may adopt rules under Chapter 119. of the Revised Code to
carry out the purposes of this chapter and shall prescribe forms relating to
notices, appeals, and requests for external review under this
chapter.

A
violation of this chapter shall be an unfair or deceptive act or practice under
sections 3901.19 to
3901.26 of the Revised Code.
Additionally, health plan issuers holding a certificate of authority from the
superintendent are also subject to the following:

(A)
If, after
notice and hearing, the superintendent of insurance finds that a health plan
issuer has failed to comply with the requirements of this chapter, the
superintendent may suspend or revoke the health plan issuer's license to
transact business within the state.

(1)
In lieu of
the suspension or revocation of a license under division (A) of this section,
the superintendent of insurance, pursuant to an adjudication hearing initiated
and conducted in accordance with Chapter 119. of the Revised Code, or by
consent of the health plan issuer without an adjudication hearing, may levy an
administrative penalty. The administrative penalty shall be in an amount
determined by the superintendent, but the administrative penalty shall not
exceed one hundred thousand dollars per violation. Additionally, the
superintendent may require the health plan issuer to correct any deficiency
that may be the basis for the suspension or revocation of the health plan
issuer's license. All penalties collected shall be paid into the state treasury
to the credit of the department of insurance operating fund.

(2)
If the
superintendent for any reason has cause to believe that any violation of the
requirements of this chapter has occurred or is threatened, the superintendent
may give notice to the health plan issuer and to the representatives or other
persons who appear to be involved in the suspected violation to arrange a
conference with the suspected violators or their authorized representatives for
the purpose of attempting to ascertain the facts relating to the suspected
violation, and, if it appears that any violation has occurred or is threatened,
to arrive at an adequate and effective means of correcting or preventing the
violation.

Proceedings shall not be covered by any formal procedural
requirements, and may be conducted in the manner the superintendent may
consider appropriate under the circumstances.

(a)
The
superintendent may issue an order directing a health plan issuer or a
representative of the issuer to cease and desist from engaging in any act or
practice in violation of the requirements of this chapter. Within thirty days
after service of the order to cease and desist, the respondent may request a
hearing on the question of whether acts or practices in violation of those
sections have occurred. Such hearings shall be conducted in accordance with
Chapter 119. of the Revised Code and judicial review shall be available as
provided by that chapter.

(b)
If the
superintendent has reasonable cause to believe that an order has been violated
in whole or in part, the superintendent may request the attorney general to
commence and prosecute any appropriate action or proceeding in the name of the
state against the violators in the court of common pleas of Franklin county.
The court in any such action or proceeding may levy civil penalties, not to
exceed one hundred thousand dollars per violation, in addition to any other
appropriate relief, including requiring a violator to pay the expenses
reasonably incurred by the superintendent in enforcing the order. The penalties
and fees collected shall be paid into the state treasury to the credit of the
department of insurance operating fund.